Legal And Ethical Aspects Of European Health Insurance: Privacy, Consent, And Regulation

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Legal And Ethical Aspects Of European Health Insurance: Privacy, Consent, And Regulation

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Differences between the European Union and the United States of America in drug regulatory matters affect global patient safety standards and public health awareness: the case of Deferasirox and other iron chelating drugs

Ethical And Legal Issues In Nursing

Received: April 1, 2021 / Revised: June 17, 2021 / Accepted: July 5, 2021 / Published: July 7, 2021

Drug regulation has a major impact on patient safety and survival. Some pharmaceutical companies employ all possible methods to achieve maximum sales in relation to the monopoly of their patented drugs, which sometimes leads to irregularities and illegal activities. Misinformation about the orphan drug deferasirox has reached the stage of criminal investigation and fines exceeding USD 100 million. The US FBI filed another $3.5 billion civil damages and fines lawsuit involving deferasirox and mycophenolic acid, which was later settled with an additional $390 million fine. In addition, a fine of 345 million USD was also settled for bribery and other illegal operations overseas including an EU country. However, no similar fines for illegal practices or violations of regulatory controls have been issued in the European Union. Misconceptions and a lack of clear guidelines for the use of deferasirox in comparison with deferiprone and deferoxamine appear to reduce the prospects of effective treatment and increase the risk of toxicity for thalassemia and other iron-loaded patients. Similar issues have been raised for the activities of other pharmaceutical companies promoting the use of new patents versus generic drugs. Treatments for different categories of patients using new patented drugs are mostly marketed with no clear guidelines or guidelines for risk/benefit assessment indications or for effective and safe individualized therapy. There is a need for the establishment of an international organization, which can monitor and evaluate the risk / benefit assessment and marketing of drugs in the European Union and globally for the benefit of patients. The leading role of drug regulatory authorities and prescribing physicians in identifying the best individualized therapies is essential to improve the survival and safety of millions of patients worldwide.

Pharmaceuticals are a major source of income especially for developing countries. Annual drug sales by the top ten global pharmaceutical companies, which are mainly involved in the sale of new patented drugs, are estimated to exceed USD 0.5 trillion [1]. There is fierce competition worldwide in the supply and sale of pharmaceutical drugs, including generic drugs and new patents.

In many cases, drug selection for the treatment of a specific condition is not clearly defined due to gaps or gaps in regulatory, marketing and other policies. This can affect the safety and long-term survival of different categories of patients [1, 2, 3, 4, 5, 6, 7]. In some cases, these problems arise from the methods used by pharmaceutical companies to achieve maximum revenue from the manufacturing and supply of their drugs by being granted exclusive worldwide patent protection and sales monopoly. Patients may end up with drug therapy that is not optimal in terms of toxicity, effectiveness and cost, mainly as a result of the interaction between the activities and policies of the government and the pharmaceutical industry [1, 2, 3, 4, 5, 6, 7, 8, 9, 10].

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There is potential for ethical and indeed legal conflict in the promotion and distribution of new patented drugs, as evidenced by past illegal activities undertaken by physicians, academics, drug regulatory authorities and patient organizations [1, 2, 3, 4, 5, 6 , 7]. Non-disclosure agreements between academics or institutions and pharmaceutical companies can lead to biased or incorrect reporting of clinical trial results [1, 2, 3, 4, 5, 6, 7]. While it is possible that these inconveniences will still be present in one form or another, it appears that in the European market, consumers and in particular patients would benefit from a stronger central framework to assess the cruelty of pharmaceutical companies and provide punitive measures when they must (Figure 1).

While great progress has been made in the regulation of the pharmaceutical industry, from the identification of lead drugs to post-marketing surveillance, there are many opportunities for the drug development process to be subverted from the benefit of patients as the main goal. Investment in clinical research comes almost exclusively from industry, which has to turn a profit, thereby modifying publications and prescribing processes that can be commercially motivated [1, 11, 12, 13].

A survey in the United States showed a weak picture for the state of contracts between academic institutions and the pharmaceutical industry, where very few research centers included standard language in their contracts that guaranteed, for example, the access of investigators to primary data from the entire . study [14].

Cases of misconduct involving physicians and the pharmaceutical industry, in relation to financial conflicts, clinical trial results, and drug prescribing patterns, have been widely reported [2, 15, 16, 17, 18, 19]. In Greece, physicians responsible for enrolling thalassemia patients to convert from generic to a more expensive new patented drug in a post-marketing surveillance study were paid EUR 5000 per patient [1, 7, 20]. Cases involving corruption of clinicians have also reached the courts. In a German case, ‘donations’ of up to EUR 10,000 were to be allowed for the promotion of medical products by private clinicians, due to the sheer number of cases. Most of the receiving physicians were also working for the German National Health System [21].

Industry Influence In Healthcare Harms Patients: Myth Or Maxim?

Therefore, there is a thin line between ethical and commercial activities by the pharmaceutical industry, academic institutions, hospitals, drug regulatory authorities and other similar bodies. In this context, self-regulation by the industry has proven in many cases inadequate to provide the best individual therapy for patients. For example, the development of drug combination therapy that can provide more effective treatment compared to monotherapy and also the development of drug antidotes to minimize toxic side effects are not encouraged by the industry for financial reasons [1, 20]. With profit taking the forefront in drug development decisions, it is perhaps not surprising that unethical or seemingly bad activities are undertaken at the expense of patients.

Misinformation about drug toxicity and efficacy, risk/benefit assessment, drug price and therapeutic index of new patented drugs compared to generic drugs can all have direct effects on patient safety and long-term survival as well as government health budgets [13, 22, 23 ]. Different rates of survival of thalassemia patients receiving iron chelation therapy were observed as a result of distribution of approval and use of deferiprone (L1) in India in 1995, the European Union in 1999 and the USA in 2011 [1]. Large differences in the sale price of the orphan chelating drugs deferasirox (DFRA), deferiprone (L1) and deferoxamine (DF) have affected their availability to patients in developing countries where health facilities and finances are scarce. In many countries, local production of deferiprone and deferasirox has mainly overcome the problem of high cost of imported formulations [1].

Further price reduction was anticipated with the expiration of the deferasirox patent in 2017. However, the new patented formulation of deferasirox with the same active ingredients and dubious policies except the generic company involved in the production will cost the public for example in Europe about 64, 700 euros. for each adult patient of 75 kg using a dose of 40 mg / kg / day. The cost of generic deferasirox production is estimated at approximately 0.1% of the sale price. This monopoly policy of patent extension is not unique to deferasirox but is observed in most other drug cases where the patent has expired and it mainly benefits large pharmaceutical companies in rich countries at the expense of public health funds and also patients in developing countries.

Marketing team in every pharmaceutical company

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